Federal Register / Vol. 78, No. 35 / Thursday, February 21, 2013 / Notices 12063 

balanced in terms of points of view 

represented and the functions to be 

performed by the advisory committee. 

Every effort is made to ensure that the 

views of women, all ethnic and racial 

groups, and people with disabilities are 

represented on HHS federal advisory 

committees. Therefore, the Department 

encourages nominations of qualified 

candidates from these groups. The 

Department also takes into 

consideration geographic diversity in 

the composition of the committee. 

Appointment to this committee shall be 

made without discrimination on the 

basis of age, race, ethnicity, gender, 

sexual orientation, disability, and 

cultural, religious, or socioeconomic 

status. 

Individuals who are appointed as 

public members of federal advisory 

committees are classified as special 

government employees (SGEs). SGEs 

who are appointed to serve as members 

of federal advisory committees are 

subject to the ethical standards of 

conduct for federal employees. Upon 

entering the position and annually 

throughout the term of appointment, the 

public members appointed to the 

ACBTSA will be required to complete 

and submit a report of their financial 

holdings, including information about 

consultancies and research grants or 

contracts, so that an ethics analysis can 

be conducted to ensure that members 

are not involved in activities in the 

private sector that may pose potential 

conflicts of interest for performance of 

their official duties for the Committee. 

Dated: February 15, 2013. 

James J. Berger, 

Senior Advisor for Blood Policy. 

[FR Doc. 2013–04036 Filed 2–20–13; 8:45 am] 

BILLING CODE 4150–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of Requirements and 

Registration for healthfinder.gov 

Mobile App Challenge; Correction 

AGENCY: Office of Disease Prevention 

and Health Promotion, Office of the 

Assistant Secretary for Health, Office of 

the Secretary, Department of Health and 

Human Services. 

ACTION: Notice; correction. 

SUMMARY: The Office of Disease 

Prevention and Health Promotion 

published a document in the Federal 

Register of December 6, 2012, 

announcing the requirements and 

criteria for the healthfinder.gov Mobile 

App Challenge. The document 

contained inaccurate wording in one 

subsection of the terms and conditions. 

FOR FURTHER INFORMATION CONTACT: Silje 

Lier, MPH, Communication Advisor, 

Office of Disease Prevention and Health 

Promotion, U.S. Department of Health 

and Human Services. Email 

Silje.Lier@hhs.gov; phone 240–453– 

6113. 

Correction 

In the Federal Register of December 6, 

2012, in FR Doc. 2012–29520, on pages 

72864–72865, in the second column, 

correct section 9 under the ‘‘Eligibility 

Rules’’ caption to read: 

(9) Each applicant retains title and 

full ownership in and to their 

submission. Applicant expressly 

reserves all intellectual property rights 

not expressly granted under this 

agreement. Applicants must agree to 

irrevocably grant to federal government 

a non-exclusive, royalty free, perpetual, 

irrevocable, worldwide license and 

right, with the right to sublicense, under 

entrant’s intellectual property rights, in 

the event that an entrant wins, to use, 

reproduce, publicly perform, publicly 

display, and freely distribute the 

submission provided by such entrant 

(with or without any modifications or 

derivative works thereto), or any portion 

or feature thereof, for a period of one (1) 

year following the date that the 

challenge winner is selected. 

Dated: February 6, 2013. 

Don Wright, 

Deputy Assistant Secretary for Disease 

Prevention and Health Promotion, Office of 

Disease Prevention and Health Promotion. 

[FR Doc. 2013–03882 Filed 2–20–13; 8:45 am] 

BILLING CODE 4150–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Meeting for Software Developers on 

the Technical Specifications for 

Common Formats for Patient Safety 

Data Collection and Event Reporting 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Patient Safety and 

Quality Improvement Act of 2005, 42 

U.S.C. 299b–21 to b–26, (Patient Safety 

Act) provides for the formation of 

Patient Safety Organizations (PSOs), 

which collect, aggregate, and analyze 

confidential information regarding the 

quality and safety of health care 

delivery. The Patient Safety Act (at 42 

U.S.C. 299b–23) authorizes the 

collection of this information in a 

standardized manner, as explained in 

the related Patient Safety and Quality 

Improvement Final Rule, 42 CFR Part 3 

(Patient Safety Rule), published in the 

Federal Register on November 21, 2008: 

73 FR 70731–70814. AHRQ coordinates 

the development of a set of common 

definitions and reporting formats 

(Common Formats) that allow health 

care providers to voluntarily collect and 

submit standardized information 

regarding patient safety events. In order 

to support the Common Formats, AHRQ 

has provided technical specifications to 

promote standardization by ensuring 

that data collected by PSOs and other 

entities are clinically and electronically 

comparable. More information on the 

Common Formats, including the 

technical specifications, can be obtained 

through AHRQ’s PSO Web site: http:// 

www.PSO.AHRQ.GOV/index.html. 

The purpose of this notice is to 

announce a meeting to discuss the 

Common Formats technical 

specifications. This meeting is designed 

as an interactive forum where PSOs and 

software developers can provide input 

on these technical specifications. AHRQ 

especially requests input from those 

entities which have used AHRQ’s 

technical specifications and 

implemented, or plan to implement, the 

formats electronically. 

DATES: The meeting will be held from 

8:30 a.m. to 4:00 p.m. on Friday, April 

26, 2013. 

ADDRESSES: The meeting will be held at 

the John M. Eisenberg Conference 

Center, Agency for Healthcare Research 

and Quality, 540 Gaither Road 

Rockville, MD 20850. 

FOR FURTHER INFORMATION CONTACT: 

Eileen Hogan, Center for Quality 

Improvement and Patient Safety, AHRQ, 

540 Gaither Road, Rockville, MD 20850; 

Telephone (toll free): (866) 403–3697; 

Telephone (local): (301) 427–1111; TTY 

(toll free): (866) 438–7231; TTY (local): 

(301) 427–1130; Email: 

PSO@AHRQ.HHS.GOV. 

If sign language interpretation or other 

reasonable accommodation for a 

disability is needed, please contact the 

Food and Drug Administration (FDA) 

Office of Equal Employment 

Opportunity and Disability Management 

at (301) 827–4840, no later than April 

10, 2013. 

SUPPLEMENTARY INFORMATION: 

Background 

The Patient Safety Act and Patient 

Safety Rule establish a framework by 

which doctors, hospitals, skilled 

nursing facilities, and other health care 


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12064 Federal Register / Vol. 78, No. 35 / Thursday, February 21, 2013 / Notices 

providers may voluntarily report 

information regarding patient safety 

events and quality of care. Information 

that is assembled and developed by 

providers for reporting to PSOs and the 

information received and analyzed by 

PSOs—called ‘‘patient safety work 

product’’—is privileged and 

confidential. Patient safety work 

product is used to identify events, 

patterns of care, and unsafe conditions 

that increase risks and hazards to 

patients. Definitions and other details 

about PSOs and patient safety work 

product are included in the Patient 

Safety Rule. 

The Patient Safety Act and Patient 

Safety Rule require PSOs, to the extent 

practical and appropriate, to collect 

patient safety work product from 

providers in a standardized manner in 

order to permit valid comparisons of 

similar cases among similar providers. 

The collection of patient safety work 

product allows the aggregation of 

sufficient data to identify and address 

underlying causal factors of patient 

safety problems. Both the Patient Safety 

Act and Patient Safety Rule, including 

any relevant guidance, can be accessed 

electronically at: http:// 

www.PSO.AHRQ.GOV/REGULATIONS/ 

REGULATIONS.htm. 

In collaboration with the interagency 

Federal Patient Safety Workgroup 

(PSWG), the National Quality Forum 

(NQF) and the public, AHRQ has 

developed Common Formats for two 

settings of care—acute care hospitals 

and skilled nursing facilities—in order 

to facilitate standardized data 

collection. The term ‘‘Common 

Formats’’ refers to the common 

definitions and reporting formats that 

allow health care providers to collect 

and submit standardized information 

regarding patient safety events. AHRQ’s 

Common Formats include: 

• Event descriptions (descriptions of 

patient safety events and unsafe 

conditions to be reported), 

• Specifications for patient safety 

aggregate reports and individual event 

summaries, 

• Delineation of data elements to be 

collected for different types of events to 

populate the reports, 

• A user’s guide and quick guide, and 

• Technical specifications for 

electronic data collection and reporting. 

AHRQ convenes the PSWG to assist 

AHRQ with developing and maintaining 

the Common Formats. The PSWG 

includes major health agencies within 

the Department of Health and Human 

Services (HHS)—the Centers for Disease 

Control and Prevention, Centers for 

Medicare & Medicaid Services, Food 

and Drug Administration, Health 

Resources and Services Administration, 

Indian Health Service, National 

Institutes of Health, National Library of 

Medicine, Office of the National 

Coordinator for Health Information 

Technology, Office of Public Health and 

Science, and Substance Abuse and 

Mental Health Services 

Administration—as well as the 

Department of Defense and Department 

of Veterans Affairs. 

When developing Common Formats, 

AHRQ first reviews existing patient 

safety event reporting systems from a 

variety of health care organizations. In 

collaboration with the PSWG and 

Federal subject matter experts, AHRQ 

drafts and releases beta versions of the 

Common Formats for public review and 

comment. 

Through a contract with AHRQ, NQF 

solicits feedback on the beta (and 

subsequent) versions of the Common 

Formats from private sector 

organizations and individuals. The 

NQF, a nonprofit organization that 

focuses on health care quality, then 

convenes an expert panel to review the 

comments received and provide 

feedback to AHRQ. Based upon the 

expert panel’s feedback, AHRQ, in 

conjunction with the PSWG, further 

revises the Common Formats. 

The technical specifications promote 

standardization of collected patient 

safety event information by specifying 

rules for data collection and submission, 

as well as by providing guidance for 

how and when to create data elements, 

their valid values, conditional and go-to 

logic, and reports. These specifications 

will ensure that data collected by PSOs 

and other entities have comparable 

clinical meaning. 

The technical specifications also 

provide direction to software 

developers, so that the Common 

Formats can be implemented 

electronically, and to PS0s, so that the 

Common Formats can be submitted 

electronically to the PSO Privacy 

Protection Center (PSOPPC) for data deidentification and transmission to the 

Network of Patient Safety Databases 

(NPSD). 

Most recently, AHRQ and the PSWG 

announced the release of Common 

Formats—Hospital Version 1.2 in the 

Federal Register on April 13, 2012: 77 

FR 22322–22324. The Common 

Format—Readmissions Version 0.1 Beta 

for analysis of the circumstances 

surrounding readmissions into acute 

care hospitals was announced in the 

Federal Register on July 20, 2012: 77 FR 

42736–42737. 

The Software Developer’s meeting 

will focus on discussion of the 

implementation and use of Hospital 

Common Formats 1.1 and 1.2; the 

technical specifications, which provide 

direction to software developers that 

plan to implement the Common Formats 

electronically; and future development 

plans for the Common Formats. The 

technical specifications are a critical 

component that allow for the 

aggregation of patient safety event data. 

The technical specifications consist of 

the following: 

Æ Data dictionary—defines data 

elements and their attributes (data 

element name, answer values, field 

length, guide for use, etc.) included in 

Common Formats; 

Æ clinical document architecture 

(CDA) implementation guide — 

provides instructions for developing a 

file to transmit the Common Formats 

Patient Safety data from the PSO to the 

PSO PPC using the Common Formats; 

Æ validation rules and errors 

document—specifies and defines the 

validation rules that will be applied to 

the Common Formats data elements 

submitted to the PSO PPC; 

Æ Common Formats flow charts— 

diagrams the valid paths to complete 

generic and event specific formats (a 

complete event report); 

Æ local specifications—provides 

specifications for processing, linking 

and reporting on events and details 

specifications for reports; and 

Æ metadata registry—includes 

descriptive facts about information 

contained in the data dictionary to 

illustrate how such data corresponds 

with similar data elements used by 

other Federal agencies and standards 

development organizations [e.g., HL–7, 

International Standards Organization 

(ISO)]. 

Agenda, Registration and Other 

Information About the Meeting 

On Friday, April 26, 2013, a premeeting seminar will convene at 8:30 

a.m. with focus on data submission, 

including discussion of technical 

specifications and aggregate reports. 

Then, the general meeting will start at 

10:00 a.m. with an overview of Federal 

efforts related to the Common Formats. 

The agenda will continue with 

presentations and discussion of 

implementations of Hospital Common 

Formats Version 1.1 and 1.2 and next 

steps for upcoming Common Formats 

releases. AHRQ staff and contractors 

will also review database functionality, 

which is available through the PSO PPC, 

for PSOs to generate aggregate reports 

with technical specifications. Finally, 

the meeting will review data submission 

both by PSOs and by vendors on behalf 

of a PSO. Throughout the meeting there 

will be interactive discussion to allow 


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Federal Register / Vol. 78, No. 35 / Thursday, February 21, 2013 / Notices 12065 

meeting participants not only to provide 

input, but also to respond to the input 

provided by others. A more specific 

agenda will be provided to meeting 

registrants before the meeting. 

AHRQ requests that interested 

persons register with the PSO PPC to 

participate in the meeting. The contact 

at the PSO PPC is Mark Baliff who can 

be reached by telephone at (866) 571– 

7712 and by email at 

SUPPORT@.PSOPPC.ORG. Additional 

logistical information for the meeting is 

also available from the PSO PPC. The 

meeting space will accommodate 

approximately 150 participants. 

Interested persons are encouraged to 

register as soon as possible for the 

meeting. Non-registered individuals will 

be able to attend the meeting in person 

if space is available. 

Prior to the meeting, AHRQ invites 

review of the technical specifications for 

Common Formats. The formats can be 

accessed through AHRQ’s PSO Web site 

at http://www.pso.AHRQ.GOV/formats/ 

commonfmt.htm. AHRQ is committed to 

continuing refinement of the Common 

Formats, and welcomes questions from 

prospective meeting participants and 

interested individuals on the technical 

specifications. These questions should 

be emailed to SUPPORT@PSOPPC.ORG 

no later than April 10th, 2013. AHRQ 

will use the input received at this 

meeting to further update and refine the 

Common Formats. 

Dated: February 7, 2013. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2013–03911 Filed 2–20–13; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Patient Safety Organizations: Delisting 

for Cause for Independent Data Safety 

Monitoring, Inc. 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of Delisting. 

SUMMARY: AHRQ has delisted 

Independent Data Safety Monitoring, 

Inc. due to its failure to correct a 

deficiency. The Patient Safety and 

Quality Improvement Act of 2005 

(Patient Safety Act) authorizes the 

listing of PSOs, which are entities or 

component organizations whose 

mission and primary activity is to 

conduct activities to improve patient 

safety and the quality of health care 

delivery. HHS issued the Patient Safety 

and Quality Improvement Final Rule 

(Patient Safety Rule) to implement the 

Patient Safety Act. AHRQ administers 

the provisions of the Patient Safety Act 

and Patient Safety Rule relating to the 

listing and operation of PSOs. 

DATES: The directories for both listed 

and delisted PSOs are ongoing and 

reviewed weekly by AHRQ. The 

delisting was effective at 12:00 Midnight 

ET (2400) on January 15, 2013. 

ADDRESSES: Both directories can be 

accessed electronically at the following 

HHS Web site: http:// 

www.pso.AHRQ.gov/index.html. 

FOR FURTHER INFORMATION CONTACT: 

Eileen Hogan, Center for Quality 

Improvement and Patient Safety, AHRQ, 

540 Gaither Road, Rockville, MD 20850; 

Telephone (toll free): (866) 403–3697; 

Telephone (local): (301) 427–1111; TTY 

(toll free): (866) 438–7231; TTY (local): 

(301) 427–1130; Email: 

psoAHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Patient Safety Act, Public Law 

109–41,42 U.S.C. 299b–21 b–26, 

provides for the formation of PSOs, 

which collect, aggregate, and analyze 

confidential information regarding the 

quality and safety of health care 

delivery. The Patient Safety Rule, 42 

CFR part 3, authorizes AHRQ, on behalf 

of the Secretary of HHS, to list as a PSO 

an entity that attests that it meets the 

statutory and regulatory requirements 

for listing. A PSO can be ‘‘delisted’’ by 

the Secretary if it is found no longer to 

meet the requirements of the Patient 

Safety Act and Patient Safety Rule. 

Section 3.108(d) of the Patient Safety 

Rule requires AHRQ to provide public 

notice when it removes an organization 

from the list of federally approved 

PSOs. 

Independent Data Safety Monitoring, 

Inc. failed to respond to a Notice of 

Preliminary Finding of Deficiency sent 

by AHRQ pursuant to 42 CFR 

3.108(a)(2) and a Notice of Proposed 

Revocation and Delisting sent by AHRQ 

pursuant to 42 CFR 3.108(a)(3)(iii)(C) 

which found that Independent Data 

Safety Monitoring, Inc. had not 

complied with its attestation to notify 

the Secretary if there has been a change 

in the accuracy of the information it 

submitted for initial listing, which 

includes contact information for the 

PSO (42 CFR 3.102(a)(1)(vi)). 

Independent Data Safety Monitoring, 

Inc. did not exercise its opportunity to 

be heard in writing to respond to the 

deficiency specified in the notices, and 

has not provided any evidence of a good 

faith effort to correct the deficiency. As 

such, pursuant to 42 CFR 

3.108(a)(4)(iii), the notice of proposed 

revocation became final as a matter of 

law and the basis for revocation. 

Accordingly, AHRQ has revoked the 

listing of Independent Data Safety 

Monitoring, Inc., PSO number P0114, 

effective at 12:00 Midnight ET (2400) on 

January 15, 2013. 

More information on PSOs can be 

obtained through AHRQ’s PSO Web site 

at http://www.pso.AHRQ.gov/ 

index.html. 

Dated: February 11, 2013. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2013–03909 Filed 2–20–13; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Institute for Occupational 

Safety and Health Personal Protective 

Technology for Pesticide Handlers: 

Stakeholder Meeting 

AGENCY: The National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of public meeting. 

SUMMARY: The National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC) 

announces the following public 

meeting: ‘‘Pesticide Handler Personal 

Protective Technology Stakeholder 

Meeting’’. 

Stakeholder Meeting Time and Date: 

4 p.m.–6 p.m. EDT, March 25, 2013 

[Optional] 

8 a.m.–6 p.m. EDT, March 26, 2013. 

Place: NIOSH, Patriots Plaza 1, 395 E. 

Street, SW., Room 9000, Washington, 

DC 20201. This meeting will also be 

accessible remotely through Live 

Meeting with advanced registration. 

Purpose of the Meeting: This meeting 

is being held to motivate and educate 

pesticide handlers and pesticide 

workers to use best pesticide personal 

protective equipment practices. This 

stakeholder meeting allows NIOSH to 

facilitate focused communication and 

exchange ideas and solutions between 

key stakeholder groups. Stakeholder 

feedback is sought to provide input to 

future updates of the NIOSH Personal 


erowe on DSK2VPTVN1PROD with NOTICES